Healthy Clinical Trial
Official title:
Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Ascending Doses And The Effect Of Food On Oral WCK 4873 In Healthy Adult Volunteers
Verified date | April 2019 |
Source | Wockhardt |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a double-blind, randomized, placebo-controlled study, consisting of a single ascending dose (SAD) part and a 2-way crossover food effect (FE) part. Each subject will participate in only one cohort during the study.
Status | Completed |
Enrollment | 67 |
Est. completion date | July 13, 2013 |
Est. primary completion date | June 25, 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - BMI : 18-30 kg/m2 (Body Mass Index [BMI] [kg/m2] = Body weight [kg] Height2 [m2]) - Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "powerdrinks"), grapefruit (juice) from 48 h prior to entry in the clinical research center until discharge - Medical history without major pathology Exclusion Criteria: - Evidence of clinically relevant pathology - Mental handicap - History of relevant drug and/or food allergies - Regular/routine treatment with non-topical medications within 30 days prior to entry into the clinical research center - Smoking within 60 days prior to drug administration and through the follow-up visit - History of alcohol abuse or drug addiction (including soft drugs like cannabis products) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wockhardt |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessing incidence of treatment emergent AEs | Incidence of treatment emergent AEs, abnormal clinical laboratory findings, variations in LFTs, abnormal physical examination findings, variations in vital signs and variations in 12-lead ECG | Day 18 | |
Primary | Evaluating PK parameters for profiling | plasma PK parameters -Area under curve (AUC0-t, AUC0-12, AUC0-24, AUC0-inf, %AUC) | Day 4 | |
Primary | Evaluating PK parameters for profiling | plasma PK parameters- maximum concentration (Cmax, Clast) | Day 4 | |
Primary | Evaluating PK parameters for profiling | plasma PK parameters tmax, tlast, kel, t½, | Day 4 | |
Primary | Evaluating PK parameters for profiling | urine PK paramters (Aeurine) | Day 4 | |
Primary | Evaluating PK parameters for profiling | feces PK paramters ( Aefeces) | Day 4 | |
Primary | Evaluating PK parameters for profiling | PMN white blood cell concentrations of WCK 4873. | Day 4 |
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